A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture and of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects

Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines [ Time Frame: Before vaccination (day 1) and three weeks after vaccination (day 22) ] [ Designated as safety issue: No ]

Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (day 1) and three weeks (day 22) after one vaccination of cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay.

In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is >70% in the ≥18 to ≤60 years of age group or >60% in the ≥61 years of age group.

Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV [ Time Frame: Three weeks after vaccination (day 22) ] [ Designated as safety issue: No ]

Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer <10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is >40% in the ≥18 to ≤60 years of age group or >30% in the ≥61 years of age group.

Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV [ Time Frame: Three weeks after vaccination (day 22) ] [ Designated as safety issue: No ]

Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is >2.5 in the ≥18 to ≤60 years of age group or >2.0 in the ≥61 years of age group.

Secondary Outcome Measures:

Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination [ Time Frame: Up to 7 days postvaccination ] [ Designated as safety issue: Yes ]

The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups.

pregnant women or women who refuse to use a reliable contraceptive method throughout the study (180 days)

any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00492063